Trial · NCT02838420
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 | From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months) | The primary analysis population for efficacy was the intent-to-treat (ITT) population, defined as all randomized participants. | Months | MEDIAN |
| SECONDARY | PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Time to Progression of Disease in the CNS as Determined by IRC Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Time to Progression of Disease in the CNS as Determined by IRC Using Response Assessment in Neuro-Oncology (RANO) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Duration of Response (DOR) Assessed by Investigator Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Overall Survival Time | Baseline, until death (up to overall period of approximately 40 months) | |||
| SECONDARY | Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events | Up to overall period of approximately 40 months | The safety population was defined as all participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Core (QLQ-C30) Score | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer Module (QLQ-LC13) Score | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |||
| SECONDARY | Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite | Baseline and Week 4 predose (within 2 hours before administration of study drug) | The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm. | Hours*nanogram/milliliter (hr*ng/mL) | MEAN |
| SECONDARY | Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite | Baseline and Week 4 predose (within 2 hours before administration of study drug) | The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm. | Nanograms/milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Cmax (Tmax) of Alectinib and Its Metabolite | Baseline and Week 4 predose (within 2 hours before administration of study drug) | The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm. | Hour (hr) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02838420/outcomes